Plasma Protein Levels and Very Preterm Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.

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Detailed Description

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Conditions

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Very Preterm Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Very preterm babies

Observational model: cohort

Evaluation of the relationship plasma protein levels - neonatal hemodynamics

Intervention Type OTHER

* Patient inclusion at birth
* Total plasma protein values measurement on cord blood sample at birth
* Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler
* Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth
* Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 \[regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy\] will be monitored over 24 hours after birth.

Interventions

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Evaluation of the relationship plasma protein levels - neonatal hemodynamics

* Patient inclusion at birth
* Total plasma protein values measurement on cord blood sample at birth
* Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler
* Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth
* Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 \[regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy\] will be monitored over 24 hours after birth.

Intervention Type OTHER